The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Well Lead All Silicone Foley Catheter With Temperature Sensor.
| Device ID | K202134 |
| 510k Number | K202134 |
| Device Name: | Well Lead All Silicone Foley Catheter With Temperature Sensor |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Well Lead Medical Co., LTD. C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou, CN 511434 |
| Contact | Jenny Zhu |
| Correspondent | Jenny Zhu Well Lead Medical Co., LTD. C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou, CN 511434 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2021-04-08 |